KREMER BLADE GAUGE— 510(k) K820050

Substantially Equivalent

Accutome, Inc.

FDA 510(k) clearance K820050 for KREMER BLADE GAUGE, Substantially Equivalent on 1982-02-24. Applicant: Accutome, Inc.. Device class: 1.

Clearance details

Applicant: Accutome, Inc.
Product code: Code HOE
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1982-01-08
Decision date: 1982-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HOE

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K813315 — CALIPER-OPTHALMIC1982-03-01
K812011 — BLADE GAUGE1981-07-28
K801937 — BLEPHAROMETER1980-09-16
K792383 — KELMAN DIPSTICK1979-12-11

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K050552 — PACHPEN PACHYMETER, MODEL 24-51002005-03-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.